Information about Military and Civilian Biodefense/Terrorism Countermeasures, vaccines, laws and policies

March 30, 2006

U.S. to Test Kits with Bioterrorism Countermeasures

Global Security Newswire

The U.S. Centers for Disease Control and Prevention plans to give 5,000 homes in the St. Louis area test kits with antibiotics to determine how people would manage drugs they are given to combat a bioterrorism attack, the St. Louis Post-Dispatch reported yesterday (see GSN, Oct. 29, 2004).

The agency beginning in April will begin screening roughly 20,000 people to determine who will receive the "MedKits."

The goal of the project is to determine the best way to distribute drugs to the public in case of an incident as well as to determine how people would store the drugs.

"This is an important project that not only helps us prepare in this area, but also helps inform national policy," said Bruce Clements, who directs the Missouri Health and Senior Service Department's Center for Emergency Response and Terrorism.

CDC spokesman Von Roebuck said the study is "still a work in progress."

"The whole idea is that if we ever had an emergency situation - say it involved smallpox - we would be able, whatever the location, to augment what states could do," he added.

The antibiotics, which were chosen because of their ability to prevent infections after exposure to virulent bacteria, will be given out in transparent bags along with instructions for use.

The kits contain either Doxycycline - a treatment for anthrax - or Ciprofloxacin, which could be used against agents such as anthrax, plague, botulism, tularemia and smallpox.

The agency plans to monitor the families that receive the kits to ensure that they are being stored properly, as well as to "explore attitudes, perceptions and other social and psychological factors" connected to the drugs, according to a Federal Register announcement.

Following the 2001 terrorist and anthrax attacks, the federal government has been trying to determine the best way to distribute drugs. Heath and Human Services Secretary Michael Leavitt said drugs might be stored in the caches around the country or could be distributed by the U.S. Postal Service.

Leavitt also was considering putting the drugs in homes, but said more work needs to be done on how this system would operate. Clements said there was no data available on the risks and benefits of home storage.

"All we have is assumptions. We know that people can be irresponsible with a variety of different drugs. But we don't know whether they would be irresponsible with these drugs. This is cutting-edge research, and we're excited in Missouri to be hosting it," he said (Bill Lambrecht, St. Louis Post-Dispatch, March 29).

DOD starts new vaccine development

UPI

The Pentagon is working on a single vaccine to counter all kinds of hemorrhagic fever like Ebola or Barburg.

It is also working on a single vaccine for all "intracellular" pathogens like the plague, said Peter C. W. Flory, the assistant secretary of defense for international security policy at a Senate Armed Services Hearing Wednesday.

The vaccine research is part of a $1.5 billion investment over the next five years to develop broad spectrum countermeasures to advanced biological weapons threats.

The standard approach has been to develop single drugs for every different bug.

The "one-drug, one-bug" approach is meant to develop countermeasures for evolving threats. If a terrorist or rogue state develops a new type of hemorrhagic fever, the super drug would conceivably be able to counter it.

The vaccine or drug would also allow U.S. forces to quickly deploy to areas where those diseases are threats.

Also Wednesday, a New Jersey pharmaceuticals company announced it had completed the first phase of a new human clinical study for a new anthrax treatment called Anthim on healthy volunteers.

Anthim is an antibody that targets the protective antigen component of anthrax, blocking the bacteria's ability to form deadly toxins, according to a company statement. The Food and Drug Administration has given it fast-track status. It can be issued as a prophylactic prior to exposure or as a treatment up to 48 hours after exposure to anthrax.

The test showed no serious adverse effects and the drug was tolerated by all volunteers in a 42-day study, according to Elusys Therapeutics Inc., of Pine Brook N.J.

Based on the results of the study, Elusys is preparing to commercially manufacture the drug in hopes of securing a government contract to produce it. Elusys received a $5 million contract from the National Institute of Allergy and Infectious Diseases and the Department of Defense to develop the drug in 2005.

March 28, 2006

New vaccine preservative proves harmful

The new preservatives used to replace methylmercury in vaccines may actually be more dangerous than mercury, straight.com reported March 23, citing a new research paper that is under peer review.

Methylmercury in vaccines is known to be toxic to the nervous system even though vaccine makers vehemently deny mercury in vaccines has any alleged association with autism.

The magnitude of the toxicity of at least one new preservative used currently in vaccines are surprisingly high, although it is expected that any preservative should be toxic at a certain level

Canadian scientists along with their US colleagues just completed a study and found that aluminum hydroxide used in vaccines was linked with symptoms associated with Parkinson's, amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), and Alzheimer's, according to straight.com.

Aluminum compounds have been known to many to harm the nervous system while aluminum hydroxide has been used in patients to stimulate immune response. But this seems to be the first study that addresses the toxicity of an aluminum compound in vaccines.

The vaccine makers use aluminum hydroxide not only as a preservative, but also as a stimulator that the vaccine makers hope can boost the efficacy of their vaccines. Aluminum hydroxide is present at least in hepatitis A and B, and the Pentacel cocktail, which vaccinates against diphtheria, pertussis, tetanus, polio, and a type of meningitis, straight.com cited the study paper.

The thing that triggered the researchers to perform the study is the Gulf syndrome. According to Chris Shaw, a Vancouver neuroscientist, the soldiers during the first Gulf War were vaccinated with an aluminum-hydroxide-loaded anthrax vaccine. It turned out that the Gulf Syndrome stroke both those who were deployed in the Gulf and those who were not at a similar rate.

To test the effects of aluminum hydroxide in the anthrax vaccine, Shaw and his four-member team from University of British-Columbia and Louisiana State University injected mice with the anthrax vaccine developed for the first Gulf War soldiers and watched what would happen.

After the 20-week study of mice, the scientists found statistically significant increases in anxiety (38 percent), memory deficits (41 times more errors), and an allergic skin reaction (20 percent). Tissue samples from the sacrificed mice showed neurological cells were dying. Inside the brains, in the part that control movement, 35 percent of cells were destroying themselves.

"No one in my lab wants to get vaccinated," Shaw was quote as saying said. "This totally creeped us out. We weren't out there to poke holes in vaccines. But all of a sudden, oh my God we've got neuron death!"

March 27, 2006

Pentagon Anthrax Scare Leads to Response Changes

Global Security Newswire

The U.S. Defense Department is making changes to its biological hazard response plans in the wake of the anthrax scares of March 2005, the American Forces Press Service reported Friday (see GSN, April 14, 2005).

An independent laboratory on March 14, 2004, alerted the Pentagon's mail screening contractor that samples taken March 10 had tested positive for anthrax. However, mail from that day was incorrectly approved for distribution.

Mail at a Defense Department mail facility in Fairfax County, Va., was placed in a biocabinet. However, the amount of mail in the cabinet blocked airflow and caused an alarm to sound. That was mistakenly believed to be indicating the presence of anthrax, according to Ellen Embrey, deputy assistant defense secretary for force health protection and readiness.

On March 18, a testing system indicated that anthrax was present at the Defense Intelligence Agency mailroom at Bolling Air Force Base in Washington.

Additional testing determined that there was no anthrax in any of the facilities.

A report by the RAND Corp. found that: the Pentagon Remote Delivery Facility ensured that personnel were separated from the threat; the Defense Department correctly notified other agencies of the incident which led to quick decisions on treating the public health issues and those potentially exposed to anthrax; and conducted a strong public health response to the incidents.

The Pentagon identified, screened, treated and offered counseling workers who might have been exposed to the agent, Embrey said. More than 800 people had been tested by March 17.

"Once we were notified that anthrax was detected in the Pentagon mail sample, the first concern was the health and safety of those who may have been exposed," Embrey said.

The primary area for improvement identified by the report was is the speed and coordination of notification, said Michael Donley, administration and management director for the Office of the Secretary of Defense.

"Especially in the Washington area, where there are multiple agency and interagency partners, we need to work harder at the process by which all the necessary folks get contacted in the appropriate timeliness," he said.

The Pentagon is preparing guidelines for notification procedures and incident command, Donley said. Incident command is to include operations, logistics, communications and public affairs.

The U.S. Health and Human Services Department, Arlington County public health and other relevant agencies would receive earlier notification in the event of a positive or seemingly positive finding, Embrey said.

New rules should require three organizations to certify that mail is free of weapons agents before it can be released, Donley said. Defense Department officials hope that will prevent mail from being delivered before it is proven safe, AFPS reported.

Bush Looked for Non-WMD Reasons for War, Memo Says

Global Security Newswire

U.S. President George W. Bush in January 2003 mentioned several options for forcing a war with Iraq in the absence of weapons of mass destruction, including assassinating Iraqi President Saddam Hussein, the New York Times reported today (see GSN, March 22).

Bush told British Prime Minister Tony Blair during a Jan. 31 meeting that his plans for invasion would not be stopped by lack of a second U.N. resolution on Iraq or inspectors' inability to find unconventional weapons in the country, according to a memo by David Manning, who was then Blair's chief foreign policy adviser.

"Our diplomatic strategy had to be arranged around the military planning," according to the memo on the discussion by the two leaders and six leading aides.

"The start date for the military campaign was not penciled in for 10 March," Manning wrote. "That was when the bombing would begin."

The meeting occurred five days before then-Secretary of State Colin Powell briefed the U.N. Security Council with evidence of Iraq's alleged WMD programs. No unconventional weapons have been found since the fall of the Hussein regime.

Blair and Bush noted at the meeting that international inspectors had not found weapons of mass destruction in Iraq, the Times reported. Bush mentioned several possible plans for leading Iraq into war, according to the memo.

"The U.S. was thinking of flying U2 reconnaissance aircraft with fighter cover over Iraq, painted in U.N. colors," the memo states. "If Saddam fired on them, he would be in breach."

Bush also said the "U.S. might be able to bring out a defector who would give a public presentation about Saddam's WMD."

Another option would be to assassinate Hussein, Bush is noted as saying in the memo.

The British press last month reported on Bush's proposals. It is not clear in the memo whether the president was speaking in an off-hand fashion, or if the proposals were included in a White House plan, according to the Times. The memo does not indicate how Blair reacted to the potential assassination of Hussein.

National Security Council spokesman Frederick Jones said that Bush's conversation with Blair did not contradict his public statements in the buildup to the March 2003 invasion.

"While the use of force was a last option, we recognized that it might be necessary and were planning accordingly," he said.

"Saddam Hussein was given every opportunity to comply, but he chose continued defiance, even after being given one final opportunity to comply or face serious consequences. Our public and private comments are fully consistent" (Don Van Natta Jr., New York Times, March 27).

High-level prewar Iraqi officials doubted whether Baghdad had weapons of mass destruction even as Hussein played up their existence in hopes of preventing an attack by Israel, United Press International reported Saturday.

Hussein adviser Ali Hassan al-Majid - also known as "Chemical Ali" - "was convinced Iraq no longer possessed WMD, but claims many within the ruling circle always believed they did," according to a report by the Iraqi Perspectives Project at the U.S. Joint Forces Command.

The CIA belief in Iraqi unconventional weapons persuaded one official in Baghdad that they existed, UPI reported.

By late 2002, Hussein was attempting to cooperate with U.N. weapons inspectors and to eliminate WMD remnants, the report states. However, the report also says there is support for U.S. weapons inspectors' postwar conclusion that Hussein planned to reconstitute chemical, biological or nuclear weapons programs once he was freed from economic sanctions, UPI reported (Pamela Hess, United Press International, March 25).

Bioterror Threat Real, Interpol Chief Says

There is no denying the threat of bioterrorism, Interpol chief Ronald Noble said today at a workshop organized by his agency in Singapore (see GSN, March 24).

"Some people still question whether the threat of bioterrorism is real, they question whether it is truly necessary to prepare for it. I have no doubt that the threat is real," he said.

"If we have the chance to take measures to protect the citizens of our nations, to help reduce the chances of our countries of becoming a target, then we have a duty to do so," he said. "Police around the world are now also beginning to recognize and respond to this threat."

Law enforcement agencies should coordinate their efforts against bioterrorism, said Ho Peng Kee, Singapore's senior minister of state for law and home affairs.

"We may not realize that a biological attack has occurred until days or even weeks later," he said. "By that time, the terrorist may already have fled the country or succumbed to the biological agent, and all the valuable investigative leads may have disappeared."

Southeast Asian terror groups have not used biological agents in attacks. However, a Malaysian biochemist has been connected to al-Qaeda's biological and chemical weapons development efforts, and a manual found in the Philippines indicated that the terrorist group Jemaah Islamiyah was interested in using biological of chemical weapons, AP reported (Christopher Torchia, Associated Press, March 27).

High temperatures and population density and inadequate public health infrastructure make Southeast Asia vulnerable to a major bioterrorism incident, AP reported. Countries in the region are subject to quickly spreading infections and epidemics, health officials said.

Malaysia, Thailand, Vietnam and other nations need to improve laws against bioterrorism, said Barry Kellman, a weapons control expert at the DePaul University College of Law in Chicago.

The United States believes North Korea has a biological weapons program and fears that weak regulations in China could promote proliferation of dual-use technology that could be used to produce biological weapons, AP reported (Christopher Torchia, Associated Press/Washington Post, March 25).

March 24, 2006

People wary of vaccinated chicken meat

DAWN GroupBy Our Staff Reporter

ISLAMABAD, Mar 23: Chicken meat lovers still reeling from the fears of Bird Flu are now wary of eating meat of vaccinated birds because of concerns about possible side effects. Ever since the virus was detected at a couple of farms in Abbotabad and Charsadda almost a month ago, most of the poultry farm owners have got their flocks vaccinated.

The vaccination drive intensified after tests by the European Union's Reference Laboratory for Avian Influenza confirmed presence of the deadly H5N1 strain of bird flu in last month's outbreak.

A local representative of the Poultry Association confirmed that all existing flocks of chickens had been administrated the vaccine imported recently.

The concerns about the consumption of vaccinated birds has come as a double blow to the industry already devastated by reports of outbreak. 'People were refraining from buying chicken despite it being one of the most popular dishes at the dining tables. But the vaccination, instead of allaying the fears, has rather made matters worse,' a poultry seller in Aabpara market said.

Lack of public information about the issue has been the biggest factor contributing to the fears, Dr Hassan Sarosh of Poultry Association said and claimed there were no side effects of the poultry vaccine.

March 23, 2006

Vaccines Show Sinister Side

By pieta woolley

If two dozen once-jittery mice at UBC are telling the truth postmortem, the world’s governments may soon be facing one hell of a lawsuit. New, so-far-unpublished research led by Vancouver neuroscientist Chris Shaw shows a link between the aluminum hydroxide used in vaccines, and symptoms associated with Parkinson’s, amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease), and Alzheimer’s.

Shaw is most surprised that the research for his paper hadn’t been done before. For 80 years, doctors have injected patients with aluminum hydroxide, he said, an adjuvant that stimulates immune response.

“This is suspicious,” he told the Georgia Straight in a phone interview from his lab near Heather Street and West 12th Avenue. “Either this [link] is known by industry and it was never made public, or industry was never made to do these studies by Health Canada. I’m not sure which is scarier.”

Similar adjuvants are used in the following vaccines, according to Shaw’s paper: hepatitis A and B, and the Pentacel cocktail, which vaccinates against diphtheria, pertussis, tetanus, polio, and a type of meningitis.

To test the link theory, Shaw and his four-scientist team from UBC and Louisiana State University injected mice with the anthrax vaccine developed for the first Gulf War. Because Gulf War Syndrome looks a lot like ALS, Shaw explained, the neuroscientists had a chance to isolate a possible cause. All deployed troops were vaccinated with an aluminum hydroxide compound. Vaccinated troops who were not deployed to the Gulf developed similar symptoms at a similar rate, according to Shaw.

After 20 weeks studying the mice, the team found statistically significant increases in anxiety (38 percent); memory deficits (41 times the errors as in the sample group); and an allergic skin reaction (20 percent). Tissue samples after the mice were “sacrificed” showed neurological cells were dying. Inside the mice’s brains, in a part that controls movement, 35 percent of the cells were destroying themselves.

“No one in my lab wants to get vaccinated,” he said. “This totally creeped us out. We weren’t out there to poke holes in vaccines. But all of a sudden, oh my God—we’ve got neuron death!”

At the end of the paper, Shaw warns that “whether the risk of protection from a dreaded disease outweighs the risk of toxicity is a question that demands our urgent attention.”

He’s not the only one considering that.

The charge that there’s a sinister side to magic bullets isn’t new. With his pen blazing, celebrity journalist Robert F. Kennedy Jr. popularized vaccine scepticism with his article arguing that mercury in vaccines causes autism, which ran in the June 2005 Rolling Stone and on-line at Salon.com. So did last year’s vaccines-linked-to- autism bestseller, Evidence of Harm by David Kirby (St. Martin’s Press). But there’s a potential public-health cost to all the controversy, according to the B.C. Centre for Disease Control.

“Vaccines have been a victim of their own success,” spokesperson Ian Roe told the Straight in a telephone interview from Ottawa. Diseases such as polio, which killed his father-in-law, are almost eradicated and therefore no longer serve as a warning to parents. But the epidemic threat is still real. “If everyone decided to not get vaccinated, we’d live in a very different world.”

Canada’s last national immunization conference, in December 2004, heard a report that vaccine coverage is sometimes low. For diphtheria, the Public Health Agency of Canada found that just 75 percent of two-year-olds are immunized; the target is 99 percent. For tetanus, just 66 percent of 17-year-olds are immunized, compared to a target of 97 percent.

Dr. Ronald Gold, the former head of the infectious-disease division at Toronto’s Hospital for Sick Children, told the conference that “we will never be without an anti-vaccine movement,” but “in reality, there is no scientific evidence for these myths.”

Shaw acknowledges that there’s a lot of pressure on parents to vaccinate their children. “You’re considered to be a really bad parent if you don’t vaccinate,” he said—and your child can’t attend public school. “But I don’t think the safety of vaccines is demarcated. How does a parent make a decision based on what’s available? You can’t make an intelligent decision.”

Conservatively, he said, if one percent of vaccinated humans develop ALS from vaccine adjuvants, it would still constitute a health emergency.

It’s possible, he said, that there are 10,000 studies that show aluminum hydroxide is safe for injections. But he hasn’t been able to find any that look beyond the first few weeks of injection. If anyone has a study that shows something different, he said, please “put it on the table. That’s how you do science.”

Neuroscience research is difficult, Shaw said, because symptoms can take years to manifest, so it’s hard to prove what caused the symptoms.

“To me, that calls for better testing, not blind faith.”

He pointed out that George W. Bush passed legislation that opens the door for the USA to order a nationwide anthrax immunization campaign, with the threat of bioterrorism.

March 21, 2006

Selling 'pandemic flu' through a language of fear

By Peter Doshi Christian Science Monitor

Traditional skepticism is missing in discussions of pandemic flu. CAMBRIDGE, MASS. - Americans consider the United States to be a country where debate flourishes. Yet with regard to avian flu, hyped sound bites predominate. When President Bush asked Congress for $7.1 billion toward "pandemic flu preparedness," even his critics replied "not enough." Meanwhile, public health officials seem obsessed with preparing for an impending crisis - even before they have established that doom is truly heading our way.

What is lacking in the overall discussion about pandemic flu is disagreement, criticism, and skepticism - once the bedrock of science - from researchers willing to question and test the data. Further, little has been done to educate the public on what exactly defines a pandemic.

First, some facts: According to the World Health Organization, the first "outbreak" of the H5N1 virus, also known as avian flu, killed six people in 1997 in Hong Kong. Since then, H5N1 has allegedly killed 97 more worldwide, the majority of whom lived in poor, rural areas and had direct contact with dead or sick birds often kept in unsanitary conditions.

These numbers do not suggest the human population faces an insurmountable threat from this virus. Peter Palese, flu scientist at Mount Sinai School of Medicine in New York, told The New York Times in a Nov. 8, 2005, article that H5N1 is a false alarm. The virus has been "around for more than a dozen years, but it hasn't jumped into the human population." The reason? It probably can't. Dr. Palese points to studies of serum collected from rural Chinese populations in 1992. The results indicated that millions of people had natural antibodies to H5N1. This suggests they had been infected and recovered without becoming noticeably or extremely sick - not the outcome one would expect from a virus as feared as this one.

The Centers for Disease Control and Prevention (CDC) estimates that 36,000 deaths in the US occur during an "average" flu season. During the last "flu pandemic" of 1968, however, they state 34,000 Americans died.

In response to an article I recently published in the British Medical Journal, questioning the reliability of US flu death statistics, the CDC countered that "it cannot be assumed a priori that pandemics will cause more mortality than interpandemic seasons." Unfortunately, this information is rarely explained to the general public.

The CDC's statement is echoed by scientists at the National Institutes of Health in Bethesda, Md. "The mild 1968 pandemic was actually exceeded by a few more recent severe A(H3N2) seasons," they say. In other words - technical jargon removed - the annual (nonpandemic) flu season can (and has often been) more deadly than a pandemic. Despite this, the World Health Organization informs readers that among the top 10 things you should know about pandemic flu: "Large numbers of deaths will occur."

If regular flu seasons can be worse than "pandemics," just what does the word mean? Many people seem unsure. The online Merriam-Webster dictionary reports that "pandemic" was the seventh most frequently looked up word in 2005. But what the dictionary doesn't tell its readers is the definition that flu scientists employ.

To influenza researchers, "a pandemic" occurs when the flu virus in wide circulation has changed more dramatically than the normal seasonal variation. While important to flu virologists, it's not clear what relevance this viral caveat holds for the average American. As historian John Barry recently put it, "The last time a new influenza virus reached pandemic levels was in 1968, but the episode was not significantly deadlier than a typical bad flu season. Few people who lived through it even knew it occurred."

Our healthcare system - and Americans' general state of health - is not in such great shape that little is left to do but spend billions of dollars on fighting so-called killers that may never come or may not have a significant impact if they do.

Certainly public health officials are sincerely interested in our well-being. Dr. Julie Gerberding, director of the CDC, stated in a telephone press conference last fall, "We've been putting an awful lot of attention on pandemic influenza, so influenza is on people's minds, and I think the factor of pandemic influenza is very frightening to people." One begins to wonder whether some officials might not cherish their worst case scenario, and even see vindication in it.

There are better ways to promote America's health than selling sickness through the language of fear. Before the government employs "all instruments of national power," including "quarantine authority," as the National Strategy for Pandemic Influenza declares, we need to be told what "pandemic flu" really means. So far, we have not been given the full story in plain language.

• Peter Doshi is a graduate student at Harvard University focusing on issues where medicine, politics, and journalism intersect.

March 17, 2006

Who Controls Medical Research?

BMJ

Is society losing control of the medical research agenda? ask experts in astudy published online by the BMJ today (17 March 2006). Medical research depends on funding from the private sector, in particular from biotechnology and drug companies, but this funding may lead to conflicts of interest about the results of medical research.

To measure the potential impact of public funding compared to industry funding, researchers analysed the affiliations of authors and the funding sources of the most frequently cited medical research papers from 1994 to 2003. Top-cited papers have a major impact on scientific thinking.

Of the 289 most frequently cited articles, most had at least one author with a university (76%) or hospital (57%) affiliation.

Government or public funding was most common (60% of articles), followed by industry (36%). However, the proportion of articles funded by industry increased over the decade and by 2001, more than 50% of funding came from industry, surpassing funding from government or public sources.

Sixty five of the 77 top-cited randomised controlled trials received funding from industry, whereas government and public sources funded only 32 trials. The proportion of trials funded by industry also increased significantly over time. Eighteen of the 32 most cited trials published after 1999 were funded by industry alone.

Participation of academics in influential medical research has remained strong, despite the perceived crisis in academic medicine, say the authors. Yet industry funds an increasing proportion of this research, especially randomised controlled trials, most of which are now funded exclusively by industry.

They suggest that the role of industry should be scrutinised further. They also believe that medical research should reflect public needs more closely and the efforts of all those involved (government, industry, and academia) should be better coordinated.

VaxGen again delays anthrax vaccine delivery

Reuters

California pharmaceutical firm VaxGen Inc. has further delayed shipment to the U.S government a new version of its anthrax vaccine, an element of the U.S. bio-warfare defense program, the Washington Post reported on Friday.

VaxGen Inc. officials said in interviews that their vaccine had failed in a key human trial, putting the company at least a year behind schedule, the newspaper said.

The Brisbane, California-based company has an $877 million contract to supply 75 million doses of the vaccine.

VaxGen said in November that it expected to begin deliveries to the government for its emergency stockpiles in the fourth quarter of 2006, instead of the first half of the year as originally planned. The delay was announced after U.S. regulators tightened requirements for the product.

President George W. Bush's Project BioShield encourages companies to develop -- and allows the government to buy -- drugs, vaccines and other products that might protect Americans against a biological, chemical or nuclear attack.

Anthrax is considered the top biological weapon threat.

The Washington Post reported that a VaxGen test completed last year found that its anthrax vaccine was unstable and lost potency within months.

VaxGen scientists said the problem was easy to fix, but they would not be certain of a solution until additional tests were completed, including another human trial slated to begin later this year, the newspaper said.

VaxGen officials acknowledged that they have no hope of meeting a deadline to deliver 25 million doses of the vaccine into a national stockpile by November, the report said.

The officials also acknowledged they would default on their contract with the government unless it granted an extension they have requested, the paper said.

According to the Post, officials at the Department of Health and Human Services declined to comment on the problem but said VaxGen was required to deliver a product of acceptable stability to the government.

No Hope for Stockpile of New Anthrax Vaccine by November

By Justin Gillis, Washington Post Staff Writer

Developer Seeks Extension After Setback on Crucial Test

The government's $1 billion effort to develop a new anthrax vaccine has run into difficulty, with the company in charge of the project reporting failure in a major human test and falling at least a year behind schedule.

Officers at VaxGen Inc. of Brisbane, Calif., said in interviews that they believe they have isolated the problem with their vaccine and are well on their way to fixing it. But they acknowledged that they have no hope of meeting a deadline to deliver 25 million doses of the vaccine into a national stockpile by November and will default on their contract with the government unless it grants an extension they have requested.

The difficulties appear to confirm predictions on Capitol Hill two years ago that a small company like VaxGen wouldn't be able to meet an aggressive schedule for stockpiling millions of doses of a new anthrax vaccine. Until the full stockpile of 75 million doses is ready, the United States would depend on antibiotics to treat a large-scale anthrax attack, a strategy that terrorists could overcome by creating antibiotic-resistant anthrax.

Administrators at the Health and Human Services Department declined to discuss specifics of the VaxGen contract. But they said that, despite some setbacks, they are building a national defense against anthrax spores, among the most fearsome of bioterror weapons. In particular, they noted, they have already stockpiled enough antibiotics to treat 40 million people after a large-scale attack.

"I think overall we are certainly making progress in our anthrax preparedness program," said Gerald Parker, the chief deputy in an HHS office that manages emergency preparations.

With the VaxGen product delayed, the government recently bought 5 million doses of an older, controversial anthrax vaccine, enough to treat fewer than 2 million people, and hopes to order more when funds are identified.

The anthrax program is emblematic of larger problems in Project BioShield, President Bush's ambitious biowarfare defense program. It's becoming clear that many of the robust national safeguards against biological and radiological terrorism that Bush promised when he got Congress to create BioShield simply won't be ready any time soon. HHS Secretary Michael Leavitt told Congress yesterday that "more can and must be done to aggressively and efficiently implement Project BioShield," and he pledged to reorganize the responsible office.

An injection of federal money into the program, $5.6 billion over a decade plus additional research funds, has piqued the interest of biotechnology companies. But many analysts say the research and development needed to create new products is moving at a glacial pace.

Moreover, most of the nation's biggest drug companies have eschewed the program, seeing little profit but big risk to their reputations if they mess up a high-profile government contract.

The government has thus had to depend on small, financially shaky biotechnology companies. Yet in contrast to the way the Pentagon buys goods, HHS lacks the legal authority to use public funds extensively to shore up companies. It can pay them up to 10 percent of the value of a contract in advance, but that isn't much -- the seemingly mundane tasks of building production lines and perfecting large-scale manufacturing techniques are riddled with pitfalls and can eat up tens or even hundreds of millions in capital.

The companies can get research subsidies early in a project, and they stand to receive hefty government payments at the end, after they deliver a product. But they must finance the expensive middle stages largely on their own. Biotech companies have dubbed that financing gap the "Valley of Death," and it remains to be seen if any of them can get to the other side of it on a major BioShield contract.

Companies have complained bitterly on Capitol Hill that the government has worsened that problem by doing a poor job of laying out its requirements and of issuing contracts expeditiously.

"There should be a sense of expediency and urgency to get these products developed and stockpiled," said Richard B. Hollis, head of Hollis-Eden Pharmaceuticals Inc., a San Diego company that has spent more than $70 million developing a treatment that would be used after a nuclear or radiological explosion. His company has been hammered in the stock market by perceived delays in the government's plans to purchase the drug.

William Hall, an HHS spokesman, said that the government is aware of companies' complaints and is trying to move rapidly but that it also has to take great care in analyzing potential terrorist threats and deciding which treatments and antidotes are worth the taxpayers' money. BioShield's funding "is not a bottomless pit," he said.

Supported by government contracts totaling close to $1 billion, the VaxGen program is a showcase of how BioShield is supposed to work. VaxGen is assigned to produce 75 million doses of vaccine, enough to treat 25 million people after an attack -- roughly equivalent to the entire populations of the Washington and New York metropolitan areas.

That stockpile was originally supposed to be in place by next year. But at the current rate it will be completed no sooner than 2008 or 2009, long after the anthrax attacks of late 2001 prompted the government to promise a better defense.

VaxGen, despite a troubled financial history, has managed to raise $148 million based on its anthrax contracts. It has built a $20 million production facility in South San Francisco, Calif., has hired a staff of 300 and is producing test lots of anthrax vaccine. Money shortages don't appear to have played any role in the recent problems with the vaccine.

But the company's finances are still wobbly, and with at least a year's delay looming before the vaccine is ready, VaxGen's ability to survive long enough to fulfill its contract with the government remains in doubt.

"The so-called Valley of Death is long and hot," said Lance Ignon, VaxGen's vice president for corporate affairs. "How we emerge will be very important -- it will send a strong signal to the rest of the industry."

Efforts are afoot on Capitol Hill to solve the financing problem by creating a biodefense agency with greater contracting powers than HHS. But the proposal has been criticized across the political spectrum because the agency would be exempt from open-government requirements.

VaxGen has been signaling problems in its vaccine program to Wall Street for many months and disclosed in early November that a year's delay was likely, sending its stock plunging 33 percent. But the scientific details of its problems were unclear before now.

In interviews recently in South San Francisco, VaxGen officers laid out the trouble in detail. They refused to release copies of data from the key human trial that their vaccine flunked, saying the material has not been fully reviewed by the government, but they showed the data to a reporter.

The test, completed last year, revealed an unexpected problem with the strength of the vaccine. Analysis eventually revealed that the vaccine was unstable -- any given batch was losing potency within months. That is a potentially disastrous problem, since the whole point of the vaccine is to sit on a shelf for years, ready for use the moment anthrax is unleashed.

Once they understood it, the VaxGen scientists said, the problem was easy to solve by adding an ingredient. But they can't be certain that fix has worked until they run additional tests, including a human test scheduled to begin later this year. HHS declined to comment on the problem but said VaxGen was required to deliver a product of acceptable stability to the government.

Hall, the HHS spokesman, noted that the government also encountered delays several years ago when it sought to stockpile smallpox vaccine but eventually solved them and acquired enough for every American.

Even when the shelf-life problem is solved, the anthrax vaccine will still be something of an unknown quantity. VaxGen licensed the vaccine from the U.S. Army, which invented it at a laboratory in Frederick, and Army tests show it should work. But naturally occurring anthrax infection is rare, so a new vaccine can't be tested for effectiveness in people. The Food and Drug Administration will have to approve it based on a combination of safety tests in people and effectiveness tests in animals.

With the new vaccine delayed, HHS is stockpiling an older vaccine made by a subsidiary of Emergent Biosolutions Inc., a Gaithersburg company. That vaccine has a checkered history, including lot-to-lot variability and a tendency to cause sore arms and perhaps more serious reactions. Some U.S. soldiers have risked court martial rather than take the vaccine.

If a large anthrax attack happened tomorrow, that vaccine plus antibiotics would be the defenses the government would have to offer people who had been exposed but weren't yet ill. When the same vaccine was offered in 2001 to people potentially exposed to letters containing anthrax spores, many Capitol Hill aides took it, but most postal workers refused, preferring to take their chances using antibiotics alone.

March 13, 2006

Tapes Indicate Hussein WMD Plans

Global Security Newswire

Audio recordings of former Iraqi leader Saddam Hussein and his aides from before the U.S.-led invasion of Iraq indicate that Baghdad planned to revive its WMD programs once international attention focused elsewhere, the Washington Times reported today (see GSN, Feb. 16).U.S. officials are reviewing the tapes and thousands of pages of Iraqi documents discovered following the fall of the regime.

"The factories are present," an aide says during a meeting with Hussein in the mid-1990s, during U.N. searches for any remaining Iraqi WMD stockpiles.

"The factories remain, in the mind they remain. Our spirit is with us, based solely on the time period," the aide says. "And (inspectors) take note of the time period, they can't account for our will."

Documents also indicated that Iraqi officials in the mid-1990s hoped to obtain uranium from Africa and looked at burying banned missiles, a U.S. official said.

It is not known, however, whether anything discussed in the recovered tapes and documents actually occurred, the official said.

Tape translator Bill Tierney, a U.N. weapons inspector in the 1990s, said that statements by Hussein's aide indicate Baghdad was moving to rearm.

"The tapes show that Saddam rebuilt his program and successfully prevented the U.N. from finding out about it," he said.

U.S.-led inspectors following the March 2003 invasion failed to find WMD stockpiles or evidence that prewar Iraq had ongoing unconventional weapons programs.

Another 500 hours of Hussein audiotapes remain to be translated and studied, while the U.S. Central Command is holding 48,000 boxes of Iraqi documents, House Intelligence Committee Chairman Peter Hoekstra (R-Mich.) told the Times. Only 68 pages have been submitted to the committee.

"I don't want to overstate what is in the documents," Hoekstra said. "I certainly want to get them out because I think people are going to find them very interesting."

"Everything [Hussein] is doing [on the tapes] is saying, 'Let's take it and hide it' with clear intent. 'As soon as this is over, we're going to be back after this,'" Hoekstra said.

Tierney said he believes Iraq dumped chemical weapons agent into its waterways and moved other weapons into Syria before the war.

The Iraq Survey Group was "lied to in a very systematic way," he said. "Lying. They were very good at it" (Rowan Scarborough, Washington Times, March 13).

U.S. Speeding Bioterrorism Medication Development

Global Security Newswire

The U.S. Food and Drug Administration has increasingly placed countermeasures against bioterrorism and natural pandemics on the fast track for approval, FDA Week reported Friday (see GSN, Jan. 20).Fast-track status can be given to drugs that fill unmet medical needs or that treat life-threatening and serious diseases, according to FDA Week.

Fears about a biological weapons attack and pandemic flu have changed the way an unmet need is defined, according to Christopher Paul-Milne, assistant director of the Tufts University Center for the Study of Drug Development. For example, although smallpox no longer exists in nature, the government wants to be prepared if the disease is used in a terrorist attack.

Milne said he believes that the fast track approval process is working. A report by Tufts University found that despite often being harder to develop, drugs on the fast track are ready in the same amount of time as less-complicated medications (FDA Week, March 10).

Scientist Says Security at Biological Labs Lacking

Global Security Newswire

A Rutgers University microbiologist said Friday that security at U.S. laboratories has failed to keep up with biological defense projects being conducted at the facilities, the Associated Press reported (see GSN, Feb. 21).

Richard Ebright said that regulations governing research into biological agents such as anthrax, tularemia and the plague are lagging behind other industries.

"The easiest way for al-Qaeda to obtain bioweapons agents would be to place someone in a U.S. bioweapons institution," he said during a biodefense seminar at Princeton University.

"This is something that needs to be prevented," Ebright added.

Centers for Disease Control and Prevention spokesman Von Roebuck disagreed, arguing that biodefense licensing procedures are effective and cover 300 research institutes.

"The safety measures are in place," he said. "These programs go through a review. To be registered, a lot of questions are asked, a lot of measures are looked at. ... This is taken very seriously."

Laura Kahn, who organized the seminar, said the "macho kind of culture" in biodefense research must be eliminated. "They view accidents with a real laissez-faire attitude," she said (Associated Press/PhillyBurbs.com, March 11).

Biowarfare and Bioterror: The Future Is Now

By Glenn Harlan Reynolds

Since the invasion of Iraq and the collapse of Saddam Hussein's biological-weapons threat, people have breathed easier about the threat of bioterrorism and biological warfare. But recent developments suggest that this relaxation is unwarranted. Indeed, there's considerable evidence that we should be much more afraid than we are, or have been.The first such warning comes from technology writer Paul Boutin, who recently set out to discover just how easy it would be for an amateur to create a dangerous biological weapon. The answer - as the title to his piece, "Biowar for Dummies" suggests - is "pretty easy, really." Instead of lethal genes, he inserted genes for fluorescence. Boutin writes:

I hadn't set foot in a lab since high school. Could I learn to build a bioweapon? What would I need? What would it cost? Could I set up shop without raising suspicions? And, most important[ly], would it work? . . .

Eventually, we fumble our way to a plastic dish full of translucent goop. If I'd been working on smallpox-and really committed to my cause-this would have been the part where I'd inject a lab animal with the stuff to see if it got sick. Then I'd give myself a dose and head off on a days-long, multi-airport, transnational suicide run. But it was just yeast. Set on top of a black light, it glowed an eerie bright blue, like a Jimi Hendrix poster. My creation ... lived.

Boutin's a smart guy, but he's no Dr. Evil. If he can get this far, others (more skilled, more committed, more, um, evil) can go farther, faster.

And they won't have to start from scratch. As a troubling new article in Technology Review demonstrates, they'll have a lot of old Soviet bioweapons work to build on. The story - researched and double-checked by Technology Review over a period of 14 months - suggests that there's a lot to work with. What's more, the threat isn't just the usual suspects: "weaponized" anthrax, smallpox, ebola and plague. It turns out that Soviet scientists were working, with some success, on considerably creepier stuff. We're talking about pathogens that cause the body to attack its own nervous system by generating antibodies against nerves' myelin sheaths; producing a virulent, pathogenic form of Multiple Sclerosis; or bugs that produce endorphins, keeping a population sedated, or perhaps even genuinely in love with Big Brother. And while the Soviets had to work hard to get anywhere on this kind of thing a couple of decades ago, what was hard for them is easier now.

"That's the essence of our story," said Jason Pontin, editor of Technology Review, in an interview Sunday afternoon. (I got an advance copy, but you should be able to read it here by the time this column is published.) "That whatever the Soviet Union did at enormous difficulty and expense, in principle can be done cheaply and easily with modern technology." What's more, it's technology that is "unregulated and not easy to regulate -- these are the common tools of biotechnology" today.

It's important, says Pontin, to distinguish between two kinds of threats. The first is the threat of biological terrorism: Individuals or small groups, brewing up deadly plagues in a basement. With modern technology, this is pretty easy to do, as Boutin demonstrated.

"If a determined malefactor wants to create a pathogen," Pontin says, "he can." The equipment is cheaply and readily available used on the Internet, the expertise is found in countless Ph.D candidates and senior lab assistants, and the basic feedstocks and reagents are commercially available without much trouble. The results are "scary and deadly, but not freaky and science fictional." They're also hard to counter. Some experts have suggested paying close attention to researchers in the field, or perhaps registering protein synthesizers and DNA sequencers, but those approaches seem more likely to add layers of bureaucracy to nonthreatening projects than to stop actual threats: Look at the unimpressive record of the International Atomic Energy Authority in controlling nuclear weaponry through similar mechanisms.

Scary and deadly is bad enough, but the "freaky and science-fictional" threat is worse, if perhaps more subtle: Pathogens tailored for particular ethnic groups. Diseases that only attack children. Psychotropic pathogens that affect people's minds - grossly, via schizophrenia or tranquilization, or subtly, by imbuing love for Big Brother. As Pontin notes, this kind of thing isn't currently within the capabilities of terrorists or small groups, but it's something we can expect from nation-states. We've never seen a technological revolution that somebody didn't try to weaponize, and here, "the revolution in biological science will provide enormous temptations to nation-states. And the stuff that nation-states will be able to do is really scary. It provides enormous possibilities for coercion and oppression, quite possibly for the most positive-seeming reasons."

The Technology Review story is troubling, but it's no huge surprise. I've been writing about this stuff for years, and while some of the Soviet research was news to me, the overall story wasn't. But Pontin reports that a lot of people in the national security establishment didn't want the article (which he describes as "the tip of the iceberg" in terms of their research and discovery regarding the potential threats) published because they didn't think it was a good idea to call attention to the subject, especially since nobody really knows what to do about the threat anyway.

Pontin disagrees, noting that the threat is not exactly secret (see this report from the NAS), even if it's underappreciated. What's more, we can't very well respond to the threat until we take it seriously.

I think that's right. You can't address a threat you're not aware of, and the threat of biological weaponry has receded from public consciousness; meanwhile, most of what the government is doing is based on countering known threats like anthrax, not on preparing for new dangers.

Both Ray Kurzweil and Senator Bill Frist have called for a "Manhattan Project" level of urgency toward biodefense, with an eye toward developing generic antiviral drugs, rapid-response vaccine production, and even more advanced techniques, yet unknown, for responding rapidly to new pathogens (whether natural or artificial in origin). This new article from Technology Review would seem to underscore the importance of such an approach. Pontin estimates that with that kind of an effort, effective responses might be a decade away. That may be soon enough. Let's hope, anyway.

March 8, 2006

Drug trials: Beyond the dark side

Daniel Altman International Herald Tribune

For drug companies, globalization has brought a double boon: new markets and new testing grounds for clinical trials. Better information technology and transport infrastructure have made monitoring the ethics of those trials somewhat easier, but experts say problems are still proliferating. One Swedish-Tanzanian trial of an HIV vaccine seems to be doing things right, however.The issue of unethical testing in developing countries received extra attention with the release last year of "The Constant Gardener," a film based on John Le Carré's novel about a Western company using Kenyans as unknowing guinea pigs for a tuberculosis drug. But real-life cases of questionable behavior have been popping up with increasing frequency, too.

Pfizer, based in New York, tested a meningitis drug called trovafloxacin in Nigeria in 1996, during an epidemic of the killer infection. Later, Nigerian families sued the company in the United States, saying their children had been entered into the study without their consent. The cases collapsed last summer over technical and jurisdictional details.

More recently, the American military's Walter Reed Army Institute of Research and GlaxoSmithKline of Britain came under fire for testing a hepatitis E drug on thousands of Nepalese soldiers. The researchers first tried to test the drug on civilians in Lalitpur, but rumors of bribes led to protests. Later, experts started asking whether the soldiers - many of whom may have been illiterate - could have understood the consent agreements they had signed and whether the effective but expensive drug would ever be available to Nepalese.

"Companies in the later clinical phases of drug development are increasingly going to developing countries, for example India, where it is basically cheaper to do it," said Dr. Hans Hogerzeil, director of medicine policy and standards at the World Health Organization in Geneva. "You have a huge number of treatment-naïve patients who have never been treated before and a lot of highly educated people and good infrastructure."

India is not the only popular destination for Western drug companies, however. Eastern Europe, Thailand, China, Brazil and Argentina are also favorite locations for trials, said Peter Lurie, deputy director of the health research group at Public Citizen, a watchdog organization in Washington.

"Before, you couldn't get back and forth to these countries the way you can now," Lurie said. "You couldn't share data electronically the way you can now. Even if people had the temptation to go overseas before because of less regulation, more compliant populations or study designs that they couldn't pull off locally, logistically it was not possible until recently. That's where globalization comes in."

Globalization has also made monitoring overseas trials easier, Lurie added, but the problem is still a long way from being solved.

"A given study in Malawi is easier to monitor now than it was before," he said. "Still, the ability to monitor what's going on in Malawi is so poor that, over all, the ability to monitor the totality of studies that are going on in the world has gone down."

That is why it's important to have clear international guidelines, with national laws backing them up, Hogerzeil said. India has been making especially good progress in this area, he said. Yet even when those standards exist, practice does not always follow policy.

"The patient really has to be informed what is being asked," Hogerzeil said. "You have to sit there. You have to explain it to them. You have to have material written in the local language."

Lurie said that even drug trials undertaken by public and nonprofit agencies sometimes fell victim to ethical problems. Still, he said, these trials almost always meet one important criterion that often is missing from corporate trials: that the local population would actually be able to buy and benefit from the drug if it proved successful.

A clear example is the Swedish-Tanzanian effort to develop a DNA-based vaccine against HIV. A prototype vaccine was tested first on Swedish citizens to make sure it did not have harmful side effects. But the prototype is not intended to treat HIV in Sweden; it is aimed at the subtypes of HIV that are most prevalent in East Africa. Later, the researchers may use the same platform to treat other subtypes.

A decade ago, the research project, which received generous funding both from Sweden's official aid agency and from the Walter Reed institute, approached a group of Tanzanian policemen to gauge the prevalence of HIV, which was higher than in Sweden. Now, after lengthy consultations in Tanzania, the researchers have contacted the same group again to test the vaccine.

Transparency has been a hallmark of the trial, said Eric Sandstrom, a professor in the department of infectious diseases at Karolinska University Hospital in Stockholm and a director of the study. He noted that the research offered no guarantee of medical benefits.

"We are very clear on that point," he said. "Anybody who volunteers for the study does it for the good of the development of the vaccine. There is no reassurance that any vaccine today can offer any protection."

The trials, which are the latest part of a 20-year history of cooperation between the two countries, are also intended to build infrastructure.

"It is as much a capacity-building exercise as it is a vaccine exercise," Sandstrom said. "The trial will not be performed as many others, that we take the specimens back to Sweden or any other country. They will be performed locally, and the local investigators will be performing the test."

Pharmaceutical companies may not be quite so altruistic, but they may still have a powerful reason for sticking to ethical practices.

"It's not in anyone's interest to do anything that would ultimately result in a drug being recalled," said a spokeswoman for Pfizer, Kate Robins. "You wouldn't spend a billion dollars if you're going to cut corners and it's going to ultimately be recalled."

"You're going to go into places where you can hold up to standards that are international," she said. "There is no easier, softer way. There just isn't."

March 6, 2006

Medarex, Inc. (Nasdaq: MEDX) and PharmAthene, Inc., a privately held biotechnology company specializing in the development of biodefense therapeutics, today announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to Valortim(TM)(MDX-1303) for the treatment of anthrax infection. Valortim is an investigational fully human antibody created using Medarex's UltiMAb Human Antibody Development System(R) that targets the Bacillus anthracis protective antigen.

The U.S. Orphan Drug Act is intended to encourage companies to develop safe and effective therapies for the treatment of rare diseases and conditions, specifically those expected to affect fewer than 200,000 people in the U.S. Orphan drug designation provides important benefits to companies such as eligibility for a special seven-year period of market exclusivity upon approval for the compound and indication with orphan designation, potential tax credits for research, potential grant funding for research and development, reduced filing fees for marketing applications, and assistance with clinical trial protocol review.

"Despite aggressive antibiotic therapy and supportive care, the anthrax attacks of 2001 resulted in a mortality rate of nearly 50%, illustrating the urgent need for more effective anthrax therapeutics," remarked David P. Wright, President and Chief Executive Officer of PharmAthene. "Our receipt of orphan drug designation for Valortim and, earlier this year, fast track designation, should facilitate a more streamlined development process through more frequent dialogue with the FDA."

Mr. Wright continued, "We believe Valortim may be the superior choice for procurement in the Strategic National Stockpile under Project BioShield. Itsmechanism of action appears to work under the same mechanism as the natural protective response to anthrax vaccine yet Valortim has the potential to provide immediate immunity compared to vaccines, which may take months to confer immunity. Animal studies have demonstrated efficacy in both pre- and post-exposure prophylaxis and treatment for anthrax infection, potentially enabling therapeutic intervention after the appearance of disease symptoms, when antibiotic therapy is progressively less effective."

Valortim is currently being evaluated in a Phase I open-label, dose-escalation clinical trial to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of a single dose of Valortim administered intravenously or intramuscularly in healthy volunteers. Results from this trial are anticipated later this year.

Preclinical studies suggest that Valortim has the potential to provide significant protection against anthrax infection when administered prophylactically, or prior to the emergence of symptoms of anthrax infection, and also may increase survival when administered therapeutically, or once symptoms become evident. In these studies, Valortim has been shown to protect both rabbits and monkeys against the lethal effects of anthrax infection when administered at the time of exposure at doses as low as 1 mg/kg. When administered to rabbits after the development of symptoms, Valortim also improved survival as late as 48 hours post-exposure as compared to controls.

March 3, 2006

FDA to speed new flu vaccines to market - Guidelines could shave up to 2 years off drug development

CNN

WASHINGTON (AP) -- Federal regulators published draft guidelines Thursday on ways to speed new flu vaccines to market for common winter influenza as well as an even deadlier strain of the virus, such as bird flu that has health officials worldwide worried about a pandemic.The guidelines, prepared by the Food and Drug Administration, spell out data the agency is requiring of manufacturers to demonstrate that new flu vaccines are safe and effective.

The public has 90 days to comment before they are finalized.

Eventually, the guidelines could knock one to two years off the time it takes to develop and license a new flu vaccine, Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, told reporters in a conference call.

Boosting the capacity to produce vaccines against the seasonal flu, which kills 36,000 Americans a year, should put the U.S. in a better position to respond to a potential global outbreak of pandemic flu, which could kill millions, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

"As we build up our capacity to respond to seasonal influenza, it will put us in good stead," Fauci told a House subcommittee Thursday.

By next year's flu season, manufacturers should be able to provide the United States with between 100 million and 120 million doses of flu vaccine. The Centers for Disease Control and Prevention, however, estimate 185 million Americans should be vaccinated against the flu each year.

The FDA hopes the guidelines will increase the robustness of the vaccine industry. Many of those guidelines reiterate FDA policies already in use, such as when the agency quickly approved last year's new flu shot Fluarix, made by a subsidiary of GlaxoSmithKline.

But others suggest that the FDA is thinking critically about how to oversee more novel approaches to flu-vaccine development currently being researched -- such as nasal-spray vaccines containing live, but weakened, strains of bird flu.

Perhaps more importantly, the guidelines make clear there are a variety of approaches to creating vaccines to fight the next pandemic.

The guidelines allow for emergency approval if a completely new super-strain of flu suddenly appears. Or, manufacturers could systematically create and stockpile a library of vaccines against brewing new strains.

They even allow for the possibility of one day vaccinating people against a potential future pandemic strain at the same time they get their regular winter flu shot.

"If that particular strain were to become the pandemic, at least we would not be naive to that strain. You could have that strategy," said Dr. Norman Baylor, head of FDA's vaccine office.

But rather than focus on any one strategy, the draft guidelines spell out different approaches to approval.

"What we really want to do is get manufacturers really ramped up, and bring on new manufacturers, so we can meet that target of making sure we have the capacity to make enough influenza vaccine ... for everyone who needs it," Baylor said.

In the case of a previously approved flu vaccine, manufacturers could tweak the vaccine for use against a new flu strain without having to seek a new license from the FDA, according to the draft documents.

Additionally, a manufacturer could receive "accelerated approval" for a new flu vaccine by performing studies showing that recipients experienced a surge in protective immune-system cells.

That kind of research can be done more rapidly than the traditional tracking of whether those recipients ever got the flu.

The FDA would, however, require follow-up studies on the new vaccines once they are in use, even in the midst of a pandemic, to be sure they work, according to the draft guidelines.

Health officials worry that bird flu, as it spreads well beyond Asia, could mutate into a strain that can be easily passed from human to human, sparking a pandemic. The World Health Organization has reported 174 human cases of bird flu, including 94 deaths.

The bird flu virus continues to evolve -- last year's strain looks different from this year's -- as it spreads, CDC Director Dr. Julie Gerberding told members of Congress.

"We need to expect a bird arriving with this pathogen in the United States," Gerberding said.

The Silence is Poisonous! - Bioweapons - The US government's Nuremburg Crime

By William Bowles

A criminal biological weapons programme that is a threat to the entire planet!Review: 'Biowarfare and Terrorism' by Francis A BoyleBefore I even begin to review this 'weapon of critical information', I urge you not only to buy it but when you've finished reading it (it's real short, so it shouldn't overly tax our attention-deficit culture), post it to your MP, Congressman, Senator, the UN, your vicar/priest/imam/holy man/rabbi; give it to your neighbour, teacher, workmate, brother, sister, mum and dad. In short, shout it out from the rooftops; that the US government is an international criminal of staggering proportions and the entire Bush administration should be indicted as war criminals and every last one locked up and the key thrown away.

Okay, what are we dealing with here? Boyle's short and impassioned book deals with the US government's illegal multi-billion dollar biological weapons programme. A programme, that as Boyle makes abundantly clear presents itself as "defensive" but of course, in order to produce a 'defense', requires the development of offensive bioweapons.

In fact, the penalties involved for engaging in even the research into biological weapons under US domestic law are life imprisonment and under certain circumstances, even the death penalty as well as impeachment for the president (followed rapidly one hopes by life imprisonment).

But not only does it deal with the illegal bioweapons programme initiated under the Reagan government, continued under Clinton and vastly expanded under the current regime, it reveals the linkage between the anthrax attack on Congress and 911; By means of this little charade, the greatest political crime in the history of the United States of America since its founding on 4 July 1776-the anthrax attacks on Congress, which served not only to deliver a terrorist threat to its members, but actually to close it down for a period-may remain officially unresolved forever. Could it truly be coincidental that two of the primary intended victims of the terrorist anthrax attacks-Senators Daschle and Leahe-were holding up the speedy passage of the pre-planned USA Patriot Act after the terrible tragedy of 11 September 2001-an Act which provided the federal government with unprecedented powers in relation to US citizens and institutions? (p. 49)

Boyle goes on

Could it be that what really happened in the fall of 2001 was the proverbial "one-two punch" against the American Republic and the U.S. Constitution by the Pentagon, the CIA, the National Security Council, the FBI and the rest of what the former Soviet Union used to call its "power ministries": NSA, DIA, NRO, etc. In other words, could America have suffered-without even remarking it-a coup d'état? (p.50)

No wonder the corporate media have ignored this small but devastating indictment of US war-making (I searched long and hard for a review of it in the MSM but to no avail). It is also in passing a savage indictment of the media which has ignored the issue entirely, from the true causes of Gulf War Syndrome through to the wholesale development of biological weapons by the US government including their supply to Saddam Hussein (straight from Fort Detrick).

Much of the book is given over to the specifics of the relevant treaties and laws on bioweapons and how the US has either ignored or attempted to circumvent them and Boyle dots the 'i's' and crosses the 't's' as he is responsible for much of the content of these treaties, so who better to understand how the US has played fast and loose with them! In exploring the nature of the US bioweapons programme Boyle also reveals the complicity of the universities and of the scientists employed in bioweapons development with billions of dollars of funding being channelled into campuses not only across the US but also overseas. He even warns them that they too are liable to life imprisonment for their work on bioweapons.

What makes Boyle's book so important is that the man, almost single-handedly was responsible for all the major legislation, both domestic and international covering the outlawing of biological weapons, in particular the Biological Weapons Convention and the Biological Weapons Anti-Terrorism Act of 1989.

The United States has had an extremely aggressive, offensive biological warfare program dating back to World War II" but for a number of reasons, in 1969 Nixon halted its bioweapons programme.

One, because it considered bioweapons "counter-productive due to "blowback"" two, because "[a] Biological Weapons Convention (BWC) prohibiting "bios" would enable the nuclear weapons states of the world to maintain, consolidate and further extend their near monopoly on WMD that had just been codified by the 1968 Treaty on the Non-Proliferation of Nuclear Weapons."

Furthermore, the US considered bioweapons the 'poor man's nuclear weapons' and was anxious that Third World countries didn't acquire them.

Finally, in 1972 the US ratified the BWC but this didn't stop the CIA from continuing its research and development of bioweapons. Moreover, the BWC had a massive loophole that did not prevent "research" for "prophylactic, protective or other peaceful purposes." Neither did the BWC prohibit their "use" in warfare.

And as Boyle states

"ominously there lurked in the bowels of the Pentagon the remnants of the old Chemical and Biological Warfare (CBW) Unit, waiting, wishing, hoping, planning, and scheming to spring back into life." (p. 21)

And when Reagan got elected in 1981, they got their wish and the Reagan administration began to pour massive amounts of money into researching and developing biological agents for what they alleged to be "defensive" purposes.

In fact, in constant dollars, under Reagan the US "expended as much money on allegedly defensive biowarfare research as it had done when the US government had on an overtly offensive and aggressive biowarfare program." (p.22)

But worse was to come.

The BWC does NOT cover genetic engineering research, the science didn't exist when the BWC was enacted, and the same genetic engineering research can be put to both defensive and offensive uses.

The line between 'research' and development is extremely blurred but according to Article 1 of the BWC, the development of bioweapons is prohibited. One way of determining whether the line has been crossed is whether the bio-agents have been aerosolized for delivery as most bioweapons are designed to be 'delivered' through the air.

And it was here that the role of universities and research institutes across the US came into their own, with billions of dollars of genetic engineering contracts handed out, all under the guise of dual-use, defensive-offensive "research". The programme was called the "Biological Defense Research Programme or BDRP."

Under Bush Jnr, the programme became the Chemical and Biological Defense Program.Boyle points out that by the late 1980s many "life-scientists" were turning into "death-scientists" using genetic engineering to develop offensive biological agents followed by the production of the allegedly "defensive" vaccine; testing the damnable things on animals; and then handing over their "research and development" to the Pentagon. "From there the Pentagon could easily produce, stockpile, deploy, and use biological weapons in further breach of BWC Article 1." (p.25)

In 1988, the Council for Responsible Genetics (CRG) asked Boyle to produce an analysis of Reagan's BDRP as a Detailed Memorandum of Law (which is included in the book). It became clear to Boyle that the university where he worked, the University of Illinois, Urbana-Champaign campus "were engaged in the development of offensive biowarfare weapons, despite their public protestations to the contrary," and Boyle points out that "American universities have a long history of willingly permitting their research agendas, researchers, institutes, and laboratories to be co-opted, corrupted, and perverted by the Pentagon and the CIA. (p.26)

The scale of the US bioweapons programme is staggering with $5.6 billion being spent on "Project Bioshield", over the next ten years, and this just one facet of US bioweapons development. Overall, the amount being spent on bioweapons development is at least $22 billion!

Boyle reveals one particularly and very relevant aspect of its bioweapons development programme; the use of countries such as Iraq to "weaponize" these novel biological agents; in other words, get Iraq to test the damn things out on Iranian troops! This is precisely what happened when the Reagan government supplied them to Iraq, via the American Type Culture Collection (ATCC) and the US Centers for Disease Control and Prevention (CDC).

"ATCC is a large private-sector scientific institute that cultures and stores every known type of disease occurring in nature for supposedly scientific purposes. It is therefore striking to note that both ATCC and CDC went along with the Reagan administration's wanton breach of BWC by shipping these weapons-specific bio-agents to Iraq." (p.32)

These shipments violated Article III of the BWC

Each State Party to this convention undertakes not to transfer to any recipient whatsoever, directly or indirectly, and not in any way to assist, encourage, or induce any State, group of States or international organizations to manufacture or otherwise acquire any of the agents, toxins, weapons, equipment or means of delivery specified in article 1 of the Convention.

Under the proposed CRG legislation "these biowarfare transshipments would have subjected these Reaganite perpetrators to life imprisonment, so they fought the CRG draft implementing legislation right up to the time of their (temporary) political demise, which occurred when Bush Sr. was elected President in November 1988."(pps.32-33)

And, not surprisingly, it's the same gang of ultra-right, anti-communists that accompanied the Reagan years who, like the bioweapons programme, had been biding their time, and were resuscitated under Bush Sr, just in time for 'Operation Desert Storm' and the forced innoculation of US (and UK) troops with both anthrax and botulin toxin vaccines "not only prior to vaccine approval by the F.D.A. but without their informed consent and thereby in clear violation of the Nuremberg Code on Medical Experimentation." (pps. 39-40)

And no wonder, as nobody knew that the "Reagan administration had surreptitiously shipped these weapons-specific biological agents to Iraq, and it was felt that Saddam Hussein had weaponized the anthrax and botulin toxin." (p.40)

Boyle makes the criminality of the US actions abundantly clear

"As always, the first illegal misstep compelled the second, which was criminal. Accordingly, what were then only experimental medical vaccines were injected into 500,000 U.S. armed forces deployed for Gulf War I by the Bush Sr. administration, as well as into the British troops similarly designated, turning the entire project into a massive live experiment, the results of which-due to its irregularity and indeed illegality-neither the scientific research community nor the Pentagon were able to counteract, since records of the effects of the vaccines were systematically NOT kept. As of today, more than 11,000 U.S. troops have died-but not from combat-and most of the rest suffer from the Gulf War Syndrome (GWS)." (p.41)

The scale of this crime against humanity surpasses that of the Nazi medical experiments conducted on the unfortunate occupants of the concentration camps. We are talking here about almost 600,000 human beings experimented on by the US government, without their knowledge or consent. And we are not even considering the crime of the effects of depleted uranium on both 'coalition' forces and the Iraqi population.

Boyle sums it up as follows

"Bush Sr., Cheny, General Colin Powell . General "Stormin'" Norman Schwarzkopf, and the rest of the U.S. military High Command inflicted a Nuremburg Crime on United States armed forces by forcing them to take these experimental medical vaccines in violation of the Nuremburg Code on Medical Experimentation." (p.41) And if you think the criminal acts committed under Reagan, Bush Sr, and Bush Jr excludes Clinton, think again.

"The Clinton administration's self-styled Neo-Liberals decided to reactivate massive Pentagon funding for dual-use, simultaneously offensive-defensive DNA genetic engineering biowarfare contracts despite the fact that the Reaganite Neo-Cons and their BDRP scientist accomplices had already "researched" most naturally occurring bio-agents to death almost a decade beforehand . These Clintonite Neo-Liberal biowarfare programs violated both the Biological Weapons Convention, and the Biological Weapons Anti-Terrorism Act of 1989, initiated by the Committee for Responsible Genetics."

Boyle deals at length with the anthrax attack on Congress following 9/11 that I referred to above, buy the book to get the details.

The crimes committed by the US as laid out in Boyle's small book are staggering and made all the more so by the fact that the MSM has ignored them almost without exception and no wonder, were the mainstream media to go for the jugular over the monstrous crimes committed by US capitalism, almost the entire government of the United States not to mention the tens of thousands of "life-scientists" who are involved in the development of these Weapons of Mass Annihilation, would have to face the reality that at the very least, they would have to serve life sentences for their crimes.

March 2, 2006

Lobbyists under scrutiny - Representative Weldon and Smallpox Vaccine

By: William Bender, Daily Local News

In late 2001, following the Sept. 11, 2001, terrorist attacks and the anthrax scare, U.S. Rep. Curt Weldon, R-7th, of Thornbury, Delaware County, went to bat for a Maryland-based biotech company that was looking to cash in on the threat of a terrorist-caused smallpox outbreak. Novavax Inc. was seeking federal funding to develop, and ultimately sell, an "inactivated," or killed virus that could potentially be used to vaccinate the entire U.S. population from a smallpox attack without the serious side effects of existing vaccines.

Weldon penned a "dear colleague" letter to members of Congress asking them to attend a briefing on the Novavax vaccine.

"There are questions about whether this type of vaccine, which utilizes a live virus, will really do the job for all Americans," Weldon wrote, referring to an older vaccine that could cause hundreds of deaths for at-risk populations if a mass immunization was required.

In the letter, which was signed by three other members of Congress, Weldon wrote that the government "needs a vaccine that can be administered before an outbreak of smallpox," USA Today reported in 2001.

A few weeks before the briefing, Novavax hired a new lobbyist to get the word out in Washington about its product.

Through Frank Rapoport, a government contracts attorney who is close to Weldon’s office, the company tapped Stefanie J. Reiser, Weldon’s fundraiser for his campaign and Committee for a United Republican Team (CURT PAC), his political action committee.

Such relationships -- lobbyists who double as congressional fundraisers and treasurers -- are coming under increased scrutiny in light of the Jack Abramoff scandal, and at least two senators are calling for legislation to prohibit them.

Reiser registered as a Novavax lobbyist on Nov. 13, 2001, records show. On Dec. 6, 2001, Weldon called the briefing.

Novavax issued a press release that read: "In opening the briefing, Congressman Weldon noted that ‘America continues to face serious threats from terrorism. I believe the potential for the use of biological or chemical agents against the U.S. is real and that we owe it to the American people to find safe and effective protections against these threats.’"

Russ Caso, who became Weldon’s chief of staff last year, said he and the congressman were both unaware that Reiser had performed any work for Novavax until it was brought to their attention this month.

Caso said Reiser worked with Weldon and other House members to arrange the smallpox briefing. Weldon declined to be interviewed on the matter.

Through his chief of staff, Weldon said: "My position is I never knew Stefanie Reiser was a lobbyist. It was never articulated to me. I took on that issue because of what was going on at the time and it seemed like a very significant issue."

Weldon also was interested in helping the company in 2001 because it was considering moving its headquarters from Columbia, Md., to his home district.

Novavax completed that relocation to the Great Valley Corporate Center in Malvern in September 2004.

"Curt was working on a good issue that could also benefit his congressional district," Caso said, denying that there was any connection between the congressman assisting Novavax and Reiser’s position as a lobbyist for the company.

Contacted last week in Reston, Va., Reiser said Weldon’s office was, in fact, aware that she was lobbying for Novavax while she was raising money for the congressman.

"They did know," she said, referring specifically to Michael Barbera, who was serving as Weldon’s chief of staff when Novavax hired Reiser.

She also said she found it difficult to believe that Weldon himself was unaware of her work for the biotech firm, which ultimately produced few results.

"Basically, all that ever happened was we had one little briefing on the Hill," Reiser, 42, said of her lobbying efforts.

Barbera hired Reiser in January 2000 to handle fund-raising duties for Weldon’s campaign committee and CURT PAC. She was replaced last year.

Prior to working for Weldon, Reiser was a lobbyist for Chambers Associates and served as former California Gov. Peter Wilson’s representative in Washington. She now works in the coffee business.

Reiser earned $54,659 as a fundraiser for Weldon’s campaign committee, records show. She was paid at least $90,000 out of CURT PAC for fundraising and reimbursements for travel, lodging and office supplies.

Reiser was paid $20,000 by Novavax, but she said the company never received any federal funding for the smallpox vaccine, the only issue she was assigned to handle.

An official at the National Institute of Allergy and Infectious Diseases, the federal agency that disperses most smallpox funding, confirmed that.

A Novavax spokeswoman would not provide information about Reiser or the status of its smallpox vaccine.

Barbera, who now serves as a Washington lobbyist with American Continental Group, said he knew Reiser was working for Novavax while serving as Weldon’s fundraiser.

"At some point, I came to be aware of it, and to be honest, I wasn’t particularly troubled with it," he said. "If it’s a legitimate company with a legitimate product that’s talking about bringing jobs to the district, it doesn’t matter who the lobbyist is. We’ll try to help."

Asked if he ever told the congressman Reiser was a Novavax lobbyist, Barbera said: "If Curt said he didn’t know, I believe him."

Reiser’s dual-role status is not uncommon in Washington, but some lawmakers have begun severing such relationships after Abramoff, once a powerful lobbyist, pleaded guilty last month to fraud and bribery charges.

Lawmakers who had accepted campaign contributions from Abramoff immediately began returning the money or donating it to charity.

Weldon donated to a local charity $2,000 he received from Abramoff and one of his clients, the Saginaw Chippewa Indian Tribe.

In the past six years alone, lobbyists have served as treasurers for at least 800 PACs and 68 campaign committees, according to a study released in October by the Center for Public Integrity.

"That’s undue influence, something that should just be banned right across the board," said Craig Holman of Public Citizen’s Congress Watch, which is pushing for legislation that would prevent lobbyists from arranging fundraisers, serving as treasurers and soliciting campaign contributions.

"There’s been a lot of criticism of that because it really does put lobbyists in close with the members (of Congress) and really gives them the inside track," said Larry Noble, executive director of the Center for Responsive Politics.

As the fundraiser for both of Weldon’s committees, Reiser helped raise hundreds of thousands of dollars a year to benefit Weldon’s campaign and those of other Republicans, from the federal to the municipal level.

Holman said lobbyists are a legitimate educational source for Washington lawmakers, but "they should not be in their face handing them money at the same time."

"The good thing is we don’t have to go out and change anything because we don’t have any lobbyists associated with our two accounts," he said.

But as of Thursday afternoon, Barbera’s biography on the American Continental Group Web site said he is "currently chairman of the Committee for a United Republican Team (CURT PAC), Congressman Weldon’s political action committee."

Asked about that position, Barbera, who has been registered as a lobbyist since 2002, said CURT PAC technically has no chairman because it does not have a board. Barbera said he "informally" works for the PAC.

By early Thursday evening, hours after Barbera was questioned about his activity on the committee, American Continental Group’s Web site had removed any mention of Barbera’s association with CURT PAC.

"I can’t explain why people put things on their resumes or bios," Caso said in response to Barbera’s claim that he was CURT PAC’s chairman.

Like other lawmakers, Caso said Weldon’s office is re-evaluating all its relationships with lobbyists by making sure all staffers document who they meet with and what topics are discussed.

"Our radar is on," he said. Representatives and senators from both parties are considering lobbying and ethics reform that would make funding earmarks more transparent, strengthen lobbyist disclosure requirements and restrict gifts from lobbyists to lawmakers.

Weldon’s office is waiting to see which bill "makes the most amount of sense," Caso said.

"The thing we have to be careful of is not to group all lobbyists into the Jack Abramoff category. They’re not all Jack Abramoffs," Caso said. "People have a right to make a living and most are very ethically and morally sound, so I would hesitate to group them all together and say they’re all bad people."

March 1, 2006

Ex-general joins team on anthrax

Special to The News Journal/DAVID W. HOWELL By GARY HABERThe News Journal

It may seem an unlikely fit for a military man to get involved with a nonprofit institution like the Fraunhofer USA Center for Molecular Biotechnology, where researchers work to develop plant-based vaccines to combat biohazards such as anthrax and plague, and diseases such as flu and sleeping sickness.Then again, James T. Hill is no ordinary military man.

A retired four-star U.S. Army general from Coral Gables, Fla., Hill's most recent post was regional combatant commander for the U.S. Southern Command in Miami. Hill headed military operations for all branches of the U.S. armed forces in Central and South America and the Caribbean. He oversaw an $880 million budget -- the size of a substantial corporation -- and was responsible for thousands of troops.

In December, Hill, 59, was named an unpaid member of the board of Fraunhofer USA, the parent organization that oversees Fraunhofer's five U.S. technology research centers, including the Center for Molecular Biotechnology at the Delaware Technology Park in Newark.

An anthrax vaccine is one of the most significant potential products the center is working on, said Vidadi Yusibov, its executive director. The U.S. government is likely to be the only customer for such a vaccine, and Hill will help that effort in a number of ways.

Hill will give advice about the military and government procurement process, Yusibov said. He will give suggestions about which form of vaccine, such as an injectable, pill, or nasal spray, would be most beneficial to and most likely to be purchased by the government.

Hill also can advise Fraunhofer about which government agencies offer grants for anthrax research, and his reputation will bring Fraunhofer added credibility, Yusibov said.

Anthrax has been a concern of the military since the 1980s, said Hill, a 36-year Army veteran who retired in January 2005.

"There's a military angle to what we're doing here," Hill said Friday during a visit to the center.

Hill, who served in Vietnam and Operation Desert Storm, knows firsthand how Fraunhofer's research could have an important impact on the armed forces. Developing an anthrax vaccine that could be easily administered to thousands of troops in the field would be an important advance, he said.

Earlier military efforts to inoculate combat troops against anthrax were cumbersome, Hill said. It was difficult to ensure an adequate supply of the vaccine, which required five shots administered over 18 months, making recordkeeping difficult as troops moved from one unit to another.

Hill, who already has made three visits to the center since joining the Fraunhofer board, brings, "an enormous experience and knowledge of the practical side of things," Yusibov said.

"This is a person who can really help us improve our planning and strategic development," Yusibov said.

Hill also serves on the board of Integrated Biopharma, a New Jersey-based company that has the license to commercialize the vaccines that the Center for Molecular Biotechnology develops. He also runs a consulting firm in Coral Gables that specializes in strategic leadership and security, military and political issues in Latin America.

Hill has attended post-graduate executive programs at the University of Virginia's business school, the John F. Kennedy School of Government at Harvard University and the Center for Creative Leadership at the University of San Diego.

He's spoken at Harvard, Massachusetts Institute of Technology and Tufts University's Fletcher School of Diplomacy, among other places.

President Bush appointed Hill to the Base Realignment and Closure Commission, which makes recommendations on which military bases should be closed.

Hill says he's excited about his role with Fraunhofer, which he sees as another way of giving back to his nation.

"I'm still serving my country,'" he said. "Just in a different manner."

Nipah Vaccine Shows Promise

Global Security Newswire

Researchers in Australia have been testing a vaccine for the animal disease Nipah, which scientists say could be used as a biological weapon, Reuters reported yesterday (see GSN, Dec. 21, 2005).Nipah killed more than 100 people and 1 million pigs in Malaysia in 1999, according to Reuters.

The vaccine is also effective against the closely related Hendra virus, which killed two Australians in 1994.

Fruit bats carry both viruses, which can move quickly from animals to humans. Researchers at Australia's Commonwealth Scientific and Industrial Research Organisation said that tests indicate the new vaccines might be effective against the viruses.

"It worked far better than we expected," said researcher Bruce Mungall. "It could be used for both human and animals but we are really focused on saving human lives in risk populations ... such as abattoir workers with the Nipah virus."

Mungall added that tests have shown that animals vaccinated with a protein component readied from the virus were protected against Nipah and Hendra.

Two additional years of work and collaboration with researchers backed by the U.S. National Institutes of Health are needed to develop the vaccine, Mungall said (Reuters/Yahoo!News, Feb. 28).